Evaluation of KAN-101 in Celiac Disease

Study Purpose

A safety study of KAN-101 in patients with celiac disease. The study has two parts:
1. Part A

- first in human study in which patients receive a single dose of KAN-101
2.

Part B - patients will receive three doses of either KAN-101 or placebo

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Interventional

Eligible Ages

18 Years - 70 Years

Gender

All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Adults aged 18 to 70 years inclusive
2. Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase
IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology
consistent with ≥ Marsh Type II or with evidence of villous atrophy
3. Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
4. Has followed a GFD for > 12 months immediately prior to study entry
5. Negative for tTG and negative or weak positive for DGP-IgA/IgG during screening
6. Male or female, and using at least 2 acceptable birth control methods or who are
sterile or postmenopausal
7. Capable of understanding and complying with protocol requirements
8. Patient understands and has signed the informed consent form
Key

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease

Additional Details

Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of
KAN-101 in patients with celiac disease on a gluten free diet (GFD).
An overview of the two parts and proposed dose groups is given below:
1. Part A (SAD): Patients will receive a single dose of KAN-101.
2. Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.

Arms & Interventions

Arms

Experimental: SAD Cohort 1

All enrolled patients will receive one dose of KAN-101 Dose A

Experimental: SAD Cohort 2

All enrolled patients will receive one dose of KAN-101 Dose B

Experimental: SAD Cohort 3

All enrolled patients will receive one dose of KAN-101 Dose C

Experimental: SAD Cohort 4

All enrolled patients will receive one dose of KAN-101 Dose D

Experimental: MAD Cohort 5

All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo

Experimental: MAD Cohort 6

All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo

Experimental: MAD Cohort 7

All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo

Interventions

Drug: - KAN-101

Intravenous (IV) infusion

Drug: - Placebo

Intravenous (IV) infusion

Contact a Trial Team

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